Manager QA Compliance T / L

Use Your Power for Purpose

Every day everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture which is both science and risk-based is flexible innovative and customer-oriented. Whether you are engaged in development maintenance compliance or analysis through research programs your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.

What You Will Achieve

In this role you will :

Oversee and maintain the Regulatory Internal Audits Inspection Readiness and Site Training Quality Systems for the site including management of any network projects which impact the site. Ensure the Quality Systems comply with cGMP standards and corporate quality standards. Partner with site management team to effectively design develop and implement programs to support business goals and site strategies.

• Manage a team of Quality professionals providing support to Operations Engineering Laboratory and Validation in subjects such as Regulatory Internal Audits Inspection Readiness and Site Training.
• Oversee hiring training and professional development of employees.
• Serve as the primary point of contact for systems under responsibility.
• Oversee and maintain the Training Quality System as the Personnel & Training Management LPO for the site.
• Ensure the Training Quality System complies with cGMP standards and corporate quality standards and ensure that all colleagues and contingent workers are qualified to perform their GMP responsibilities.
• Provide support through regulatory inspections readiness and processes (e.g. FDA PMDA ANVISA EMA).
• Ensure the site Quality Processes and Systems are robust effective consistent and compliant with regulatory requirements through internal audits.
• Provide data and support to the Quality Review Board to meet Corporate initiatives and ensure compliance with procedures.
• Establish and monitor metrics and drive continuous improvement of quality system.
• Expand cross-functional organizational capacity by collaborating across departments on priorities functions and common goals.

Here Is What You Need (Minimum Requirements)

experience; OR a masters degree with at least 2 years of experience; OR

a PhD with 0 years of experience; OR as associates degree with 8 years

of experience; OR a high school diploma (or equivalent) and 10 years of

relevant experience

PHYSICAL / MENTAL REQUIREMENTS

This position will spend significant time in an office environment however may be required to work in a production warehouse or laboratory environment as appropriate and must be able to wear all required PPE including aseptic gowning.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Work Location Assignment : On Premise

The annual base salary for this position ranges from $102900.00 to $171500.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver / parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and / or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing please email . This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and / or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control

Required Experience :

Manager

Key Skills

Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 102900 - 171500